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FDA gives HDE (humanitarian device exemption) approval for gastric stimulation system

The US FDA has approved Medtronic's implantable electrical stimulation device for treating patients with a rare but severe and often life-threatening form of gastroparesis, a gastrointestinal disorder marked by chronic vomiting and nausea.

The US FDA has approved Medtronic's implantable electrical stimulation device for treating patients with a rare but severe and often life-threatening form of gastroparesis, a gastrointestinal disorder marked by chronic vomiting and nausea.

The company's Enterra therapy, which was approved under humanitarian device exemption (HDE) regulations, uses a neurostimulator, which is implanted beneath the skin in the lower abdomen, to deliver pulses to...

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